The impact of vacuum-assisted excision in the management of indeterminate B3 lesions in the NHS Breast Screening Programme in England.

AIM: To assess the impact of vacuum-assisted excision (VAE) on the management of B3 lesions in the England NHS Breast Screening Programme following an update of national guidance. A secondary aim was to investigate the histological features of malignancies resulting from upgrade of B3 lesions by either VAE or surgery. MATERIALS AND METHODS: The study population was all women recalled for assessment after breast screening who had a wide-bore needle biopsy with a B3 result over the period 01/04/2018 to 31/03/2019. Data were extracted from the National Breast Screening Service (NBSS) computer system at unit level. Women with a B3 result were split into those with and without atypia. The upgrade rates and histological features of malignancies in the different groups were analysed. RESULTS: In total, 2,234,514 women attended for screening between 1/4/218 and 31/3/2019, 84,559 women were referred to assessment, and of those 40,037 women had a core biopsy resulting in 3,355 were B3 lesions (8.38%). Within these, 556 cancers were diagnosed, giving an upgrade rate of 16.57% (556/3,355). The upgrade for B3 lesions with atypia was significantly higher than for B3 lesions without atypia (29.1% versus 13.3%, p<0.001). CONCLUSION: The introduction of the new B3 guidelines has resulted in 73.8% of B3 lesions with atypia and 65.1% of B3 lesions with no atypia having VAE rather than surgery. The data highlights the importance of managing these indeterminate lesions appropriately with an overall upgrade rate of 16.57%.

Residual lymph node tumour burden following removal of a single axillary sentinel lymph with macrometastatic disease in women with screen-detected invasive breast cancer.

BACKGROUND: Women with screen-detected invasive breast cancer who have macrometastatic disease on axillary sentinel lymph node biopsy (SLNB) are usually offered either surgical axillary node clearance (ANC) or axillary radiotherapy. These treatments can lead to significant complications for patients. The aim of this study was to identify a group of patients who may not require completion ANC. METHODS: Data from the NHS Breast Screening Programme between 1 April 2012 and 31 March 2017 were interrogated to identify women with invasive breast carcinoma and a single sentinel lymph node (SLN) with macrometastatic disease who subsequently proceeded to completion ANC. Univariable and multivariable analyses were performed to identify patients with a single positive SLN who had no further lymph node metastasis on ANC. RESULTS: Of the 2401 women included in the cohort, the presence of non-sentinel node disease was significantly affected by: the number of nodes obtained at SLNB (odds ratio (OR) 0.49 for retrieval of more than 1 node), invasive size of tumour (OR 1.63 for size greater than 20 mm), surgical treatment (OR 1.34 for mastectomy), human epidermal growth factor receptor (HER) 2 status (OR 0.71 for HER2 positivity), and patient age (OR 1.10 for age less than 50 years; OR 1.46 for age greater than 70 years). Patients aged less than 70 years, with tumour size smaller than 2 cm, more than one node retrieved on SLNB, and who had breast-conserving surgery had a lower chance of positive non-sentinel nodes on completion ANC compared with other patients. CONCLUSION: This study, of a purely screen-detected breast cancer cohort, identified a subset of patients who may be spared completion ANC in the event of a single axillary SLN with macrometastasis.

Role of performance metrics in breast screening imaging - where are we and where should we be?

The NHS Breast Screening Programme (NHSBSP) was started in 1988 and is a large, organised cancer screening programme. It is delivered by 80 services across England and screens over 2 million women each year. As a screening programme, it must balance the detection of cancers against possible harm to women who do not have cancer. The NHSBSP was therefore designed with detailed information gathering and performance metrics right from the start. In this review paper, we examine how performance metrics in screening mammography have improved the national screening programme and the further developments and challenges that are expected in the years to come.

Contralateral breast cancer: incidence according to ductal or lobular phenotype of the primary.

AIM: To identify differences in the incidence of contralateral breast cancer between patients with a primary tumour diagnosis of invasive ductal carcinoma (IDC) and those with a diagnosis of invasive lobular carcinoma (ILC). MATERIALS AND METHODS: Data from two large cancer registries (registry A & B) the Northern and Yorkshire Cancer Registry Information Service (NYCRIS) and the West Midlands Cancer Intelligence Unit (WMCIU) from 1998-2003 for all cases of invasive breast cancer of either pure ductal or pure lobular reported histology were obtained. The invasive status of the contralateral tumour diagnosis and tumour morphology was collected. Chi-square tests were undertaken to examine the differences in contralateral rates for both registries and univariate analysis to ascertain which predictors affected contralateral breast cancer risk for registry A the WMCIU cases. RESULTS: A total of 38,132 patients were studied, 32,735 patients with IDC and 5397 (14.2%) patients with ILC over the 6-year period. There was no significant difference between the occurrence and time to occurrence of contralateral breast cancer according to original cancer histology, 901 (2.8%) patients with IDC versus 166 (3.1%) patients with ILC (p=0.169). The analysis of registry A cases showed no association between original histology (ductal versus lobular), age at diagnosis, tumour grade, use of radiotherapy for the primary cancer or use of systemic therapy (chemotherapy and/or endocrine therapy), and development of a contralateral breast cancer. CONCLUSION: There is no apparent increase in risk of developing a contralateral breast cancer according to the primary cancer histology either IDC or ILC. Standard mammographic follow-up does not need to take account of original tumour pathology. Increased intervention or post-treatment surveillance for the contralateral breast is not indicated in the context of ILC. The role of MRI should be restricted to those patients with ILC who are planning breast-conservation surgery, but not for assessing the contralateral breast.

Ethnicity, deprivation and screening: survival from breast cancer among screening-eligible women in the West Midlands diagnosed from 1989 to 2011.

BACKGROUND: Social inequalities in breast cancer survival are smaller when the cancer is screen-detected. We examined survival from screen-detected and non screen-detected breast cancer by ethnicity and deprivation. METHODS: Cancer registry data for 20 283 women aged 50-70 years, diagnosed between 1989-2011 and invited for screening, were linked with screening and ethnicity data. We examined Asian, Black and White groups, less deprived and middle/more deprived women. Net survival was estimated using ethnic- and deprivation-specific life tables. Estimates were corrected for lead-time bias and over-diagnosis. RESULTS: Net survival varied by screening history. No significant differences in survival were found by ethnicity. Five-year net survival was 90.0% (95% CI, 89.3-90.8%) in less deprived groups and 86.7% (85.9-87.4%) among middle/more deprived women. Screening benefitted all ethnic and both deprivation groups. Whether screen-detected or not, more deprived women had significantly poorer outcomes: 5-year net survival was 78.0% (76.7-79.2%) for deprived women who were not screen-detected compared with 94.0% (93.1-95.1%) for less deprived women who were screen-detected. CONCLUSIONS: The three ethnic groups differed little in their breast cancer survival. Although screening confers a survival benefit to all, there are still wide disparities in survival by deprivation. More needs to be done to determine what underlies these differences and tackle them.

Variations in the management of the axilla in screen-detected ductal carcinoma in situ: evidence from the UK NHS breast screening programme audit of screen detected DCIS.

The diagnosis and surgical management of screen-detected Ductal Carcinoma In Situ (DCIS) remains controversial including a range of axillary approaches and consequent morbidity. This study examined the management of the axilla in all patients with DCIS presenting through the United Kingdom National Health Service Breast Screening Programme (UK NHS BSP). Retrospective analysis of the UK NHS BSP identified 26,696 women initially diagnosed with DCIS over the 8 years 1 April 2003-31 March 2011. The final breast pathology of these women was upgraded to invasive ductal cancer in 5564 (20.8%) women or micro-invasive cancer in 1031 (3.9%) women. At first operation, 5290 (26.3%) of the 20,094 women who had a final post-operative diagnosis of DCIS only underwent axillary surgery (72.4% at the time of mastectomy, 23.8% breast conservation surgery, 3.8% axillary surgery alone). Performance of axillary surgery reflected increasing tumour size, micro-invasion or increasing nuclear grade for the final diagnosis of DCIS. More extensive nodal surgery was performed in those undergoing mastectomy; 10.8% of women had more than 8 nodes removed. Overall, 12.0% of women with invasive cancer, 1.7% with micro-invasion, and 0.2% with DCIS alone, were ultimately node positive. Improved pre-operative sampling of DCIS, axillary assessment by ultrasound with needle biopsy for suspected metastases, risk stratification for sentinel node biopsy (for high grade or extensive DCIS) and avoiding axillary clearance for a pre-operative diagnosis of DCIS alone should reduce unnecessary axillary surgery. Standards using such criteria for axillary surgery in screen-detected DCIS should be integrated into the NHS BSP.

A population based study of variations in operation rates for breast cancer, of comorbidity and prognosis at diagnosis: failure to operate for early breast cancer in older women.

BACKGROUND: Older women are less likely to have surgery for operable breast cancer. This population-based study examines operation rates by age and identifies groups which present with early or late disease. METHODS: 37 000 cancer registrations for 2007 were combined with Hospital Episode Statistics comorbidity data for England. Operation rates were examined by age, ethnicity, deprivation, comorbidity, screen-detection, tumour size, grade and nodal status. Early and late presentation were correlated with Nottingham Prognostic Index (NPI) groups and tumour size. RESULTS: The proportion of women not having surgery increased from 7-10% at ages 35-69 to 82% from age 90. From age 70, the proportion not having surgery rose by an average of 3.1% per year of age. Women with a Charlson Comorbidity Index score of ≥1 (which increased with age), with tumours >50 mm or who were node positive, were less likely to have surgery. Although women aged 70-79 were more likely to have larger tumours, their tumours were also more likely to have an excellent or good NPI (p < 0.001). Good prognosis tumours were more likely to be screen-detected, and less likely in women aged 0-39, the deprived and certain ethnic groups (p < 0.02). CONCLUSIONS: From age 70 there is an increasing failure to operate for breast cancer. Younger women and certain ethnic groups presented with more advanced tumours. Older women had larger tumours which were otherwise of good prognosis, and this would not account for the failure to operate which may in part be related to comorbidity in this age group.

Reoperation rates after breast conserving surgery for breast cancer among women in England: retrospective study of hospital episode statistics.

OBJECTIVES: To examine whether rate of reoperation after breast conserving surgery is associated with patients' characteristics and investigate whether reoperation rates vary among English NHS trusts. DESIGN: Cohort study using patient level data from hospital episode statistics. SETTING: English NHS trusts. PARTICIPANTS: Adult women who had breast conserving surgery between 1 April 2005 and 31 March 2008. MAIN OUTCOME MEASURE: Reoperation rates after primary breast conserving surgery within 3 months, adjusted using logistic regression for tumour type, age, comorbidity, and socioeconomic deprivation. Tumours were grouped by whether a carcinoma in situ component was coded at the time of the primary breast conserving surgery. RESULTS: 55,297 women had primary breast conserving surgery in 156 NHS trusts during the three year period. 11,032 (20.0%, 95% confidence interval 19.6% to 20.3%) women had at least one reoperation. 10,212 (18.5%, 18.2% to 18.8%) had one reoperation only; of these, 5943 (10.7%, 10.5% to 11.0%) had another breast conserving procedure and 4269 (7.7%, 7.5% to 7.9%) had a mastectomy. Of the 45,793 women with isolated invasive disease, 8229 (18.0%) had at least one reoperation. In comparison, 2803 (29.5%) of the 9504 women with carcinoma in situ had at least one reoperation (adjusted odds ratio 1.9, 95% confidence interval 1.8 to 2.0). Substantial differences were found in the adjusted reoperation rates among the NHS trusts (10th and 90th centiles 12.2% and 30.2%). CONCLUSION: One in five women who had breast conserving surgery in England had a reoperation. Reoperation was nearly twice as likely when the tumour had a carcinoma in situ component coded. Women should be informed of this reoperation risk when deciding on the type of surgical treatment of their breast cancer.

The effect of DCIS grade on rate, type and time to recurrence after 15 years of follow-up of screen-detected DCIS.

BACKGROUND: The incidence of ductal carcinoma in situ (DCIS) rose rapidly when the NHS Breast Screening Programme (NHSBSP) started in 1988. Some authorities consider that this represents both over-diagnosis and over-treatment. We report long-term follow-up of DCIS diagnosed in the first 10 years (April 1988 to March 1999) of the West Midlands NHSBSP. METHODS: 840 noninvasive breast cancers were recorded on the national breast screening computer system. Following exclusions, and thorough case note and pathology review, 700 DCIS cases were identified for follow-up. RESULTS: After a median follow-up of 183 (range 133 to 259) months, 102 (14.6%) first local recurrences were identified, 49 (48%) were invasive. Median time to first noninvasive recurrence was 15 months, and 60 months for invasive recurrence. Median time to invasive recurrence was 76 months from initially high-grade DCIS, and 131 months from low/intermediate grade DCIS. For the seven women, presenting with metastasis as their first event, the median time was 82 (range 15 to 188) months. The cumulative proportion developing recurrence at 180 months was twice as high as at 60 months. INTERPRETATION: Short-term follow-up of patients diagnosed with DCIS will miss significant numbers of events, especially invasive local recurrences.

Explaining the difference in prognosis between screen-detected and symptomatic breast cancers.

BACKGROUND: We analysed 10-year survival data in 19,411 women aged 50-64 years diagnosed with invasive breast cancer in the West Midlands region of the United Kingdom. The aim was to estimate the survival advantage seen in cases that were screen detected compared with those diagnosed symptomatically and attribute this to shifts in prognostic variables or survival differences specific to prognostic categories. METHODS: We studied tumour size, histological grade and the Nottingham Prognostic Index in very narrow categories and investigated the distribution of these prognostic factors within screen-detected and symptomatic tumours. We also adjusted for lead time bias. RESULTS: The unadjusted 10-year breast cancer survival in screen-detected cases was 85.5% and in symptomatic cases 62.8%; after adjustment for lead time bias, survival in the screen-detected cases was 79.3%. Within narrow categories of prognostic variables, survival differences were small, indicating that the majority of the survival advantage of screen detection is due to differences in the distributions of size and node status. CONCLUSION: Our results suggested that a combination of lead time with size and node status in 10 categories explained almost all (97%) of the survival advantage. Only a small proportion remained to be explained by biological differences, manifested as length bias or overdiagnosis.

Radiological and pathological size estimations of pure ductal carcinoma in situ of the breast, specimen handling and the influence on the success of breast conservation surgery: a review of 2564 cases from the Sloane Project.

BACKGROUND: The Sloane Project, an audit of UK screen-detected non-invasive carcinomas and atypical hyperplasias of the breast, has accrued over 5000 cases in 5 years; with paired radiological and pathological data for 2564 ductal carcinoma in situ (DCIS) cases at the point of this analysis. We have compared the radiological estimate of DCIS size with the pathological estimate of DCIS size. We have correlated these sizes with histological grade, specimen-handling methods, particularly the use of specimen slice radiographs, and the success or failure of breast-conserving surgery (BCS). METHODS: The Sloane Project database was interrogated to extract information on all patients diagnosed with DCIS with complete radiological and pathological data on the size of DCIS, nuclear grade, specimen handling (with particular reference to specimen radiographs) and whether primary BCS was successful or whether the patient required further conservation surgery or a mastectomy. RESULTS: Of 2564 patients in the study, 2013 (79%) had attempted BCS and 1430 (71%) had a successful single operation. Of the 583 BCS patients who required further surgery, 65% had successful conservation and 97% of them after a single further operation. In successful one-operation BCS patients, there was a close agreement between radiological and pathological DCIS size with radiology tending to marginally overestimate the disease extent. In multiple-operation BCS, radiology underestimated DCIS size in 59% of cases. The agreement between pathological and radiological size of DCIS was poor in mastectomies but was improved by specimen slice radiography, suggesting specimen-handling techniques as a cause. CONCLUSION: In 30% of patients undergoing BCS for DCIS, preoperative imaging underestimates the extent of disease resulting in a requirement for further surgery. This has implications for the further improvement of preoperative imaging and non-operative diagnosis of DCIS so that second operations are reduced to a minimum.

Clinical outcome data for symptomatic breast cancer: the Breast Cancer Clinical Outcome Measures (BCCOM) Project.

BACKGROUND: Data collection for screen-detected breast cancer in the United Kingdom is fully funded, which has led to improvements in clinical practice. However, data on symptomatic cancer are deficient, and the aim of this project was to monitor the current practice. METHODS: A data set was designed together with surrogate outcome measures to reflect best practice. Data from cancer registries initially required the consent of clinicians, but in the third year anonymised data were available. RESULTS: The quality of data improved, but this varied by region and only a third of the cases were validated by clinicians. Regional variations in mastectomy rates were identified, and one-third of patients who underwent conservative surgery for the treatment invasive breast cancer were not recorded as receiving radiotherapy. CONCLUSION: National data are essential to ensure that all patients receive appropriate treatment for breast cancer, but variations still exist in the United Kingdom and further improvement in data capture is required.

Follow-up for screen-detected ductal carcinoma in situ: results of a survey of UK centres participating in the Sloane project.

AIMS: To investigate the variations in follow-up practice for screen-detected ductal carcinoma in situ (DCIS) in the UK. METHODS: A questionnaire enquiring about follow-up practice and the perceived value of clinical follow-up after surgery for screen-detected DCIS was sent to the 74 UK screening centres participating in the Sloane Project. RESULTS: Responses were received from 66 hospitals serving 54 screening centres. These demonstrate wide variations in practice. Clinical follow-up duration ranges from 1 year to indefinite, with the frequency of visits from three-monthly to annually. Formal mammographic follow-up duration ranges from none to indefinite. Mammographic frequency ranges from 1 to 2 years. Follow-up varies according to factors such as size and grade of disease and margin status in 23 units and according to whether adjuvant therapy is given in 23. Seven hospitals perform mammography of reconstructed breasts. Thirty-one centres consider clinical follow-up of DCIS to be of value or limited value whereas 28 consider it to be of little or no value. CONCLUSIONS: There is no consensus with regard to the duration and frequency of follow-up for screen-detected DCIS, the contribution of predictive and treatment factors, the use of mammography of the reconstructed breast or the perceived value of clinical follow-up. Published guidelines show no consensus. Multidisciplinary teams involved in the care of women with screen-detected non-invasive cancer should contribute to audits such as the Sloane Project in order to determine the most effective and efficient ways to treat and follow up these patients.

Non-operative diagnosis--effect on repeat-operation rates in the UK breast screening programme.

Non-operative diagnosis rates in the UK breast screening programme have improved dramatically from 48.8% in 1994/95 (only nine units achieved the then minimum standard of 70%) to 94% in 2005/06 (only seven units failed to achieve the target of 90%). Preoperative and operative history of all 120,550 women diagnosed with screen-detected breast cancer in the UK between April 1994 and March 2006 was derived from different national databases. In 2005/06, 2,790 (17.8%) of the 15,688 women having surgery needed two or more operations. In 2001/02 (non-operative diagnosis rate 87%), the re-operation rate was 23.8% (2,377 of 9,969). Extrapolation backwards to 1994/95 (non-operative diagnosis rate 48.8%) suggests a re-operation rate of 62%. Analysis over the 4 years from April 2002 (n=34,198) demonstrates that 4,089 (12%) women with a correct non-operative diagnosis of invasive disease required additional surgery compared to 1,166 (48%) of women who were under-staged (diagnosed as non-invasive based on core biopsy, but actually suffering from invasive disease). Failure to achieve a non-operative diagnosis of invasive disease (n=1,542) or non-invasive disease (n=2,247) resulted in re-operation rates of 65 and 43% respectively. Given the impact of not having a diagnosis pre-operatively, or of under-staging invasive carcinoma, it seems timely to introduce more sophisticated standards.

Management of patients taking antiplatelet or anticoagulant medication requiring invasive breast procedures: United Kingdom survey of radiologists' and surgeons' current practice.

AIM: To determine the current practice in the UK National Health Service Breast Screening Programme for invasive diagnostic procedures and surgery in patients taking anticoagulant and antiplatelet medication. MATERIALS AND METHODS: Lead radiologists and surgeons at each breast screening service were surveyed to determine current practice. One hundred and five respondents provided information regarding their services, protocols, and willingness to proceed with combinations of procedures and anti-haemostatic medications. RESULTS: Between units there was wide variation in practice. Within 21 services providing more than one response, 10 (48%) disagreed on whether protocols existed. Decisions to perform biopsies were unrelated to professional group. The taking of a drug history was variable. Surgeons reported more adverse effects than radiologists [21 (48%) versus 12 (26%)], but no difference in self-assessment of knowledge. CONCLUSION: Both radiologists and surgeons have expressed uncertainty about their understanding of anticoagulant and antiplatelet treatment. This is reflected in a wide range of practice. Guidance regarding the management of these patients is suggested.

Radiotherapy following breast-conserving surgery for screen-detected ductal carcinoma in situ: indications and utilisation in the UK. Interim findings from the Sloane Project.

Use of radiotherapy (RT) after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS) varies according to country, precedent and prejudice. Results from a preliminary analysis of the data available within the UK Sloane Project can be appreciated in the context of the uncertainty concerning the selection of adjuvant RT following BCS for DCIS. There was a marked geographical variation in the use of RT within the United Kingdom. However, overall, patients with DCIS treated with BCS were significantly more likely to have RT planned (and given) if they had large (> or =15 mm), intermediate or high-grade tumours or if central comedo-type necrosis was present. Unexpectedly, margin width did not appear to have a significant effect on the decision-making process. However, the Van Nuys Prognostic Index did significantly affect the chances of getting planned RT in the univariate analysis, suggesting that clinicians may be starting to use this scoring system in routine practice to assist in decision making.